Implementing Evidence Based Treatment of Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00265538
First received: December 12, 2005
Last updated: August 6, 2014
Last verified: August 2014

December 12, 2005
August 6, 2014
July 2006
August 2009   (final data collection date for primary outcome measure)
The percent of patients taking thiazide diuretics at their index visit and at 6 and 12 months; The percent of patients at blood pressure treatment goal at 6 and 12 months; and Mean blood pressure at 6 and 12 months [ Time Frame: 1-3 months after enrollment, at first opportunity for regularly scheduled primary care visit. ] [ Designated as safety issue: No ]
1) the percent of patients taking thiazide diuretics at their index visit and at 6 and 12 months; 2) the percent of patients at blood pressure treatment goal at 6 and 12 months; and 3) mean blood pressure at 6 and 12 months
Complete list of historical versions of study NCT00265538 on ClinicalTrials.gov Archive Site
% of Patients who talked to their providers about meds at the 1st visit, $ & # of anti-HTN meds, AE's, HTN med compliance, O/P lab tests used during primary care visits, # of visits to clinics & ER's, PT knowledge of their blood pressure meds. [ Time Frame: 1-3 months after enrollment, at first opportunity for a regularly scheduled primary care visit. ] [ Designated as safety issue: No ]
1) the percent of patients who initiated discussions with their providers about thiazides at the index visit; 2) cost and number of anti-hypertensive medications; 3) adverse drug events; 4) hypertension medication compliance; 5) outpatient laboratory
Not Provided
Not Provided
 
Implementing Evidence Based Treatment of Hypertension
Implementing Evidence-based Treatment of Hypertension

This study examines the use of patient initiated discussions of blood pressure medication in the primary care setting. Additionally, this study examines different levels of patient incentive(s) to initiate discussions with providers including information only, information plus 20$ incentive and reimbursement for 6 months of copay, and information/monetary incentive plus a reminder call prior to the index visit. Patient opinions about doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors will be analyzed as well.

Patients will be randomized to Pure control, intervention control, intervention group a, intervention group b or intervention group c. Pure control patients will not receive any study information about diuretics and their providers will not see any patients who receive our study intervention letter. Patients in the intervention control group will not receive the intervention but will see providers who have other patients in the intervention groups. Patients in intervention group a will receive a customized letter prior to their next primary care appointment with information regarding the patient's specific blood pressure, current blood pressure medication and recommendation for switching or adding a thiazide. Patients in group b will receive the customized intervention letter as well as a 20$ incentive for discussing the information with their provider and a copay reimbursement for 6 months if a prescription is written for a thiazide. Patients in group c will receive the intervention letter, 20$ discussion incentive, copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care visit.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Hypertension
  • Behavioral: Patient education to engage provider in hypertension treatment discussion
    Patients will receive a customized/tailored letter including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s)
  • Behavioral: Financial incentive and health educator phone call
    Patients may receive 20$ for discussing the intervention letter with their provider and 6 months copay reimbursement and/or the 20$ discussion incentive, 6 months copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care appt.
Arm 1
Patient Intervention arms: pure control (no intervention letter); intervention control (patient does not receive intervention letter, but provider sees other patients who may bring in letter); group a (intervention letter only); group b (intervention, + 20$ incentive for discussion w/ provider and 6 month copay reimbursement); group c (intervention letter, 20$ incentive for discussion w/ provider + copay reimbursement, plus reminder phone call 1-3 days prior to primary care visit)
Interventions:
  • Behavioral: Patient education to engage provider in hypertension treatment discussion
  • Behavioral: Financial incentive and health educator phone call

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

The eligible population includes patients less than 80 years of age enrolled in primary care clinics at the study sites that meet the following additional inclusion criteria:

  • No active prescription for a thiazide diuretic (or a medication that combines a thiazide and another agent (e.g., hydrochlorothiazide and triamterene)
  • Prior diagnosis of hypertension, as documented in VA outpatient administrative files
  • Two or more visits to a primary care clinic in the prior 12 months;
  • Blood pressure above treatment goal at the two most recent VA outpatient clinic visits Above goal is defined as a systolic pressure >140 mmHg or diastolic pressure >90 mmHg. For diabetics above goal is defined as systolic pressure >130 mmHg or diastolic pressure >80 mmHg
  • Blood pressure at goal (as defined above) during one of the last two outpatient clinic visits, but the patient is receiving a prescription for a calcium channel blocker (CCB)

Exclusion Criteria:

Patients meeting the above inclusion criteria will be excluded for the following reasons:

  • Documented allergy to thiazides or to sulfa agents
  • Previously documented intolerance or adverse drug reaction to thiazide diuretics
  • Active prescription for a loop diuretic agent (e.g. furosemide)
  • Renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min
  • No serum creatinine in the past year (to permit calculation of a creatinine clearance)
  • Prior history of hypokalemia or serum potassium less than 3.5 meq/l in the prior year
  • Diagnosis of gout or active prescription for allopurinol
  • Congestive heart failure (CHF) due to systolic dysfunction with a documented left ventricular ejection fraction < 35% by echocardiography, nuclear medicine study, or ventriculography
  • Residence in a long-term care facility
  • No telephone for follow-up calls
  • Life-expectancy < 6 months
  • Inability to give informed consent or impaired cognitive function (defined as > 4 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire82, administered during study intake)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00265538
IMV 04-066
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Peter J. Kaboli, MD MS VA Medical Center, Iowa City
Department of Veterans Affairs
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP